A draft guideline from the World Health Organization intends to clarify regulatory expectations for the assessment of mAbs used for preventing and treating infectious diseases in health emergencies and to help with international harmonization efforts in this field.
The World Health Organization has published a draft guideline on the development and evaluation of monoclonal antibodies (mAbs) for tackling infectious diseases that recommends the use of regulatory flexibilities and reliance among regulators to speed up product development in times of health emergencies such as a pandemic.
Existing WHO guidance on mAbs mainly focuses on their use for non-communicable diseases, even though they “potentially offer a real-time...
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To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
An ongoing collaborative initiative involving global regulators assessing post-approval manufacturing changes has highlighted the need to establish a standardized platform that can facilitate the submission and regulatory evaluation of such changes.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
